A growing number of interventional procedures may be performed percutaneously by using one or more catheters to access treatment areas in the patient's vasculature or other regions. Although many procedures typically gain access through the femoral artery, certain access related complications are associated with this entry point. For example, major bleeding complication, retroperitoneal bleeding, blood transfusion, pseudoaneursym, difficult to achieve hemostasis following the completion of the procedure, prolonged period of immobilization, are more likely to happen with transfemoral approach. Larger the entry hole in the femoral artery, more likely are the above-mentioned complications. Correspondingly, it may be desirable to catheterize other vessels to reduce or avoid such complications or catheterize the femoral artery with a smaller diameter entry hole.
One suitable technique for catheterization is to gain access through the radial artery located in the patient's wrist. Transradial catheterization offers a number of benefits compared to the femoral approach, including a reduction in bleeding complications and more rapid ambulation. However, certain challenges are associated catheterization of this small size vessel. For example, spasm, pain and/or discomfort may occur. Radial artery catheterization may also lead to iatrogenic radial artery occlusion. Still further, radial catheterization limits the overall diameter of the guide catheter being used may be limited to 6 French size in most patients, precluding the ability to perform some of the more complex coronary, peripheral endovascular and structural cardiac intervention procedures. The important predictors of radial artery spasm during transradial catheterization include a smaller size body mass index, smaller radial artery, and larger “sheath diameter to radial artery diameter index.” As will be appreciated, spasm may lead to pain, irritation and inflammation, reducing the success rate of transradial catheterization. Likewise, the most important predictors of radial artery occlusion after transradial catheterization include the sex of the patient, as females typically exhibit relatively smaller vessel diameters, and the use of a 6 French (or larger) sheath. Therefore, all of these challenges result from the relatively smaller diameter of the radial artery and the corresponding increased potential for stretching, expanding or irritating the artery by inserting a device having an outer diameter larger than the inner diameter of the radial artery.
These challenges are exacerbated when a sheath is employed in the catheterization procedure. Since the guide catheter is delivered through the sheath, it necessarily must have a greater outside diameter. The outer diameter of a sheath is on average 0.60 millimeter larger than the corresponding size catheter. To address this situation, attempts have been made to develop sheathless systems. Some approaches nevertheless still require a radial sheath and thus are not true sheathless systems. Currently available sheathless systems are expensive and increase costs by requiring use of a new system with each guide catheter exchange. Currently available sheathless systems also require specific configurations of the guide catheter being used with the system, and correspondingly limit the choice of catheter size and shape, potentially preventing the operator from using a preferred guide catheter shape or design.
Accordingly there is a need for a device and method for transradial catheterization that allows the use of an increased diameter guide catheter by avoiding the necessity of deploying the guide catheter through a sheath. Further, it would be desirable to facilitate the exchange of guide catheters while providing sheathless access. Still further, it would be desirable to allow the use of any guide catheter of choice, such as of any size, shape and/or manufacturer. As will be described in the following materials, this disclosure satisfies these and other needs.